AIDS Groups Worried About Backlash Against Nevirapine Use in Pregnant Women, Say Drug Only Way to Prevent MTCT

Some HIV/AIDS treatment groups have expressed "alarm" about a possible backlash against the use of the antiretroviral drug nevirapine among pregnant women to reduce the risk of mother-to-child HIV transmission because of a recent series of Associated Press articles concerning clinical trials of the drug, the New York Times reports (McNeil, New York Times, 12/21). The articles concerned NIH's research on the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to reduce the risk of vertical HIV transmission. The initial results from the research, which began in 1997, showed that the drug prevented HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists, an auditor with NIH and the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 to review the trial and take corrective steps. Earlier this month, Edmund Tramont, director of the National Institute of Allergy and Infectious DiseasesDivision of AIDS, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report, 12/20).

"Furor" in Africa
According to the Times, the Associated Press articles have "created a furor" in Africa, as public health experts worry that some countries will discontinue use of the drug to reduce the risk of mother-to-child HIV transmission. Although groups treating people living with HIV/AIDS on the continent -- including Medecins San Frontieres and the Elizabeth Glaser Pediatric AIDS Foundation -- say that long-term use of nevirapine has possible risks, such as liver failure and rashes, they also contend that the risks "had been known for years and that short-term use was often the only way to save a baby's life," the Times reports. "The truth about nevirapine is getting widely misrepresented," Rachel Cohen of MSF's Access to Essential Medicines Campaign in the United States said. She added that in Africa, many women -- who comprise the majority of the 38 million HIV-positive people worldwide -- only seek medical care shortly before giving birth and HIV-positive women often have advanced to the later stages of the disease. In these circumstances, it is "too late to do anything" but administer a single dose of nevirapine to both the woman and infant at a total cost of approximately $5, according to the Times. Although the World Health Organization recommends a six-week course of nevirapine and zidovudine combination therapy when possible because of recent studies indicating that even single doses of nevirapine can result in drug resistance, this combination regimen costs about $40. Therefore, nevirapine monotherapy is still used when it is the "only chance to save a baby from infection," the Times reports (New York Times, 12/21).

Adherence Affects Resistance, Doctors SayMakerere University in Kampala, Uganda, the Johns Hopkins University School of Medicine and EGPAF on Monday released a joint statement saying that nevirapine can cause drug resistance in pregnant women only if patients "ignore doctors' orders on how to take the pills," Reuters reports. The statement -- which was issued by Laura Guay, associate professor of pathology and pediatrics at Hopkins, and Dr. Phillipa Musoke, head of pediatrics at Makerere Medical School -- aimed to "clarify the scientific facts, based on the full body of evidence." The statement did not comment on the recent reports concerning the Ugandan clinical trials of nevirapine, according to Reuters. "It is true that resistance has been shown to occur in those receiving short-course nevirapine. The problem of drug resistance has partly been as a result of violations in prescription rules. However, to date, there is no evidence of negative clinical outcomes as a result of subsequent antiretroviral therapy," the statement said (Nyakairu, Reuters,12/20).

South African Opposition Parties Urge Continued Nevirapine Use
South African opposition parties have called for the continued use of nevirapine to reduce the risk of mother-to-child HIV transmission in response to a letter posted on the ruling party's Web site last week, South Africa's Business Day reports (Mabuza, Business Day, 12/20). Last week, the African National Congress accused the United States of treating Africans like "guinea pigs" and "entering into a conspiracy" with a German pharmaceutical manufacturer to conceal potential adverse effects of nevirapine. The letter also implied that there had been numerous deaths because of nevirapine use that had been covered up by U.S. officials "to promote their own ends" (Kaiser Daily HIV/AIDS Report, 12/20). Costa Gazi, a spokesperson for the Pan Africanist Congress, said that "hundreds of thousands" of HIV-positive women in countries such as South Africa and Brazil have taken the drug "without any side effect," according to Business Day. "The ANC is still angry that the Constitutional Court ordered government to supply HIV-positive mothers with a drug to prevent the transmission of the virus to their children. President (Thabo) Mbeki has not yet grasped the fact that the deadliest enemy facing the country is the scourge of HIV," Gazi said. Butch Steyn, a spokesperson for the Democratic Alliance, said that nevirapine currently is the only feasible method of preventing vertical HIV transmission, according to Business Day (Business Day, 12/20).

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